LWR · Heart-Valve, Non-Allograft Tissue
· Class 3
Overview
| Product Code | LWR |
|---|---|
| Device Name | Heart-Valve, Non-Allograft Tissue |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P170006 | AVALUS(TM) BIOPROSTHESIS | Medtronic, Inc. | Jul 31, 2017 | APPR |
| P150048 | EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) | Edwards Lifesciences, LLC | Jun 29, 2017 | APPR |
| P150036 | EDWARDS INTUITY ELITE VALVE SYSTEM | Edwards Lifesciences, LLC | Aug 12, 2016 | APPR |
| P150011 | PERCEVAL SUTURELESS HEART VALVE | Corcym S.r.l. | Jan 8, 2016 | APPR |
| P130011 | FREEDOM SOLO STENTLESS HEART VALVE | Corcym Canada Corp | Jun 24, 2014 | APWD |
| P100029 | ST JUDE MEDICAL TRIFECTA VALVE | ABBOTT MEDICAL | Apr 20, 2011 | APPR |
| P060025 | ATS 3F AORTIC BIOPROSTHESIS | Medtronic, Inc. | Oct 30, 2008 | APWD |
| P060038 | MITROFLOW AORTIC PERICARDIAL HEART VALVE | Corcym Canada Corp | Oct 23, 2007 | APWD |
| P040021 | SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE | ABBOTT MEDICAL | Aug 5, 2005 | APPR |
| P970031 | MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS | Medtronic, Inc. | Nov 26, 1997 | APPR |
| P970030 | TORONTO SPV VALVE | St. Jude Medical, Inc. | Nov 4, 1997 | APWD |
| P790007 | HANCOCK MODIFIED ORIFICE BIOPROSTHESIS | Medtronic Heart Valves | Nov 15, 1979 | APPR |
Top Applicants
- Medtronic, Inc. — 3 clearances
- ABBOTT MEDICAL — 2 clearances
- Corcym Canada Corp — 2 clearances
- Edwards Lifesciences, LLC — 2 clearances
- Corcym S.r.l. — 1 clearance
